Agency IQ

FEBRUARY 23, 2024

I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling.

Science

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

FDA

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

Biosimilars

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

Drugs

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

FDA

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

The Pharma Data

FEBRUARY 8, 2021

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess – ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)]. Learn more at www.janssen.com.

Pharmaceutical Companies

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations

Drug Target Review

NOVEMBER 27, 2024

Advanced techniques like liquid chromatography tandem mass spectrometry (LC-MS/MS) and Meso Scale Discovery (MSD) provide the kind of comprehensive and reliable data increasingly favoured by regulators, yet many researchers continue to rely exclusively on enzyme-linked immunosorbent assay (ELISA). This is a misconception.

Drug Development